Senior Specialist, QA Material Disposition (Biopharmaceutical)

Location: Mississauga, Ontario, Canada

Salary: CAD 70,000–107,500 per year

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.

What you will do

• Review, approve, and maintain raw material specifications, supplier documentation, testing data, laboratory records, and associated quality records.
• Make release, rejection, and hold disposition decisions in accordance with cGMP requirements and site SOPs.
• Lead investigations into discrepancies, OOS results, and deviations, including root-cause analysis and CAPA closure.
• Review and approve deviation reports, OOS investigations, CAPAs, change controls, SOPs, work instructions, and other controlled documents.
• Support material release activities for regulatory submissions and stability programs.
• Serve as the QA Material Disposition subject matter expert during regulatory inspections, corporate audits, and client audits.

Requirements

• Advanced knowledge of material record review and disposition processes.
• Independent, in-depth knowledge of cGMP requirements for biopharmaceutical material release, including Health Canada, FDA, and PMDA expectations.
• Experience leading investigations related to material disposition discrepancies, OOS results, and deviations.
• Experience authoring and approving SOPs and controlled documents related to material disposition.
• Strong critical thinking, attention to detail, risk assessment, and cross-functional communication skills.
• Ability to understand, read, write, communicate, and follow instructions in English.

Nice to have

• Bachelor’s degree or higher in Life Sciences, Chemistry, or a related scientific discipline.
• 4+ years of progressive QA Material Disposition experience in a GMP-regulated biopharmaceutical or pharmaceutical environment.
• Experience with Veeva Vault QMS, LIMS, SAP, or similar computerized quality and manufacturing systems.
• Knowledge of Health Canada, FDA, and EMA/EU Annex 1 GMP requirements.
• Active participation in regulatory inspections.

Culture & Benefits

• Full-time employment with an annual cash bonus program.
• RRSP/DPSP retirement plan with company matching.
• Healthcare, dental, vision, life, LTD, and AD&D benefits.
• Fertility and family-forming benefits, paid vacation, paid holidays, and pregnancy and parental leave top-up.
• Tuition reimbursement and employee referral program.
• Work may include extended hours, evenings, and weekends based on operational needs; physical duties may include lifting up to 10 lbs.